📊 Evidence-Based Reference
Durasheath Introducer Sheath System
Summary: The Durasheath Introducer Sheath System is a medical device used primarily for vascular access in embolization procedures. Key evidence highlights its role in facilitating minimally invasive interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142357 ↗
Decision Date ?
June 25, 2015
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Durasheath Introducer Sheath System was cleared via the FDA 510(k) pathway on June 25, 2015. It is manufactured by Contract Medical International and is classified as a Class 2 device.
What It Is
The Durasheath Introducer Sheath System is designed to provide vascular access for the delivery of embolization coils. It facilitates the introduction of devices into the vascular system, ensuring a stable and secure pathway.
FDA-Cleared Indications
- Provides vascular access for the introduction of embolization coils and compatible interventional devices.
- Supports catheter-based embolization procedures requiring access to the vascular system.
Clinical Applications
- Obtaining vascular access for coil embolization procedures.
- Providing a stable access pathway during treatment of selected aneurysms or pseudoaneurysms.
- Providing vascular access during embolization of selected arteriovenous malformations.
- Supporting catheter delivery during other FDA-cleared embolization procedures when the sheath, catheter and embolic device are compatible.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, spanning from 2024 to 2025.
Reported Outcomes
Published studies report that the Durasheath Introducer Sheath System is effective in providing reliable vascular access for embolization procedures. It has been associated with improved procedural efficiency and patient outcomes in minimally invasive interventions.
Safety Profile
Reported complications include potential flow impedance when additional devices are introduced through the sheath. However, overall safety profiles in the studies reviewed indicate a low incidence of adverse events.
Evidence Limitations
The current evidence is limited by the small sample sizes and the short duration of follow-up in some studies. Further research is needed to establish long-term outcomes and to explore the device's efficacy in diverse patient populations.
Practical Considerations
- The sheath size and length must match the planned catheter, guidewire and embolization device; exact available sizes should be confirmed in the current manufacturer labeling.
- Use requires appropriate vascular access, commonly through the femoral or radial artery, with imaging guidance and sterile technique.
- The system should be flushed and handled according to the instructions for use to reduce the risk of air entry, clot formation and device damage.
- MRI safety depends on the specific components and whether the system remains in the patient; consult the current labeling before MRI.
- Potential access-site and procedure-related risks include bleeding, hematoma, thrombosis, infection, vessel injury and embolic complications.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Durasheath Introducer Sheath System?
The device is indicated for use in embolization procedures requiring vascular access, such as treating aneurysms and arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies have reported effective vascular access and improved procedural efficiency with the use of the Durasheath Introducer Sheath System.
What complications have been reported?
Safety data indicate potential flow impedance when additional devices are used, but overall adverse events are low.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.